Blade, Scalpel
FDA product code GES · Class I (low risk) · 21 CFR 878.4800 · General, Plastic Surgery
48510(k) clearances
0PMA approvals
11recalls
Manufacturers
- Aeroceuticals 4
- Medelec Intl. Corp. 3
- Imm Enterprises , Ltd. 3
- Keisei Medical Industrial Co., Ltd. 2
- Lukens Corp. 2
- American Safety Razor Co. 2
- Vxtra Corp. 2
- Coburn Optical Ind., Inc. 1
- Miltex Instrument Co. 1
- Surgimed Corp. 1
- Omi Manufacturing Pty., Ltd. 1
- Perry, Div. 1
- An-Med Intl. 1
- Anapach Effort, Inc. 1
- Stryker Corporation 1
- Needle Industries(Usa), Inc. 1
- Santa Barbara Medco, Inc. 1
- Technical Resources, Inc. 1
- Edward Weck, Inc. 1
- Richard-Allan Medical Ind., Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K032242 | Personna Plus Safety Scalpel SystemGES · Traditional | Omi Manufacturing Pty., Ltd. | 09/23/2003SE |
| K932998 | Easy-OnGES · Traditional | Devon Industries, Inc. | 08/18/1993SE |
| K923170 | Los Alamos Retractable KnifeGES · Traditional | Innovative Surgical Technology, Inc. | 02/18/1993SE |
| K915119 | Scalpel Blade Remover (Bladegard)GES · Traditional | Intergrated Visual, Inc. | 05/05/1992SE |
| K911913 | Precision Glide - Enhanced Surgical BladeGES · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 05/13/1991SE |
| K900266 | Sterile Carbon Steel Surgical BladeGES · Traditional | Rahn Laboratories | 03/01/1990SE |
| K884862 | Anchor Double-Edge Myringotomy BladeGES · Traditional | Anchor Products Co. | 12/27/1988SE |
| K881638 | Surgical BladeGES · Traditional | Far East Intl. Trading Corp. | 06/15/1988SE |
| K880244 | Surgical BladesGES · Traditional | Ailee C/O Havel'S, Inc. | 02/10/1988SE |
| K873493 | Ninja ScalpelGES · Traditional | Primrose Medical, Inc. | 09/24/1987SE |
| K873142 | Personna Disposable ScalpelGES · Traditional | American Safety Razor Co. | 09/04/1987SE |
| K863885 | Sable BladesGES · Traditional | Sable Industries | 10/24/1986SE |
| K863867 | Dextra Disposable BladesGES · Traditional | Storz Instrument Co. | 10/24/1986SE |
| K863214 | Keisei Micro-Blades (Sterile and Non-Sterile)GES · Traditional | Keisei Medical Industrial Co., Ltd. | 09/02/1986SE |
| K863211 | Keisei Surgical Blades (Sterile & Non-Sterile)GES · Traditional | Keisei Medical Industrial Co., Ltd. | 09/02/1986SE |
| K855104 | Angiomed Skin Fascia KnifeGES · Traditional | Angiomed U.S., Inc. | 01/24/1986SE |
| K854860 | Blades, Scalpel Carbon SteetGES · Traditional | Medelec Intl. Corp. | 12/24/1985SE |
| K854859 | Blades, Scalpel Stainless SteelGES · Traditional | Medelec Intl. Corp. | 12/24/1985SE |
| K854620 | Surgical BladesGES · Traditional | Niraj Industries | 12/17/1985SE |
| K854561 | Blade, ScalpelGES · Traditional | Medelec Intl. Corp. | 12/02/1985SE |
| K853528 | Stainless Steel & Carbon Steel Sterile BladesGES · Traditional | Abco Dealers, Inc. | 09/24/1985SE |
| K852661 | Apollo Sterile BladesGES · Traditional | Orthofab, Inc. | 07/11/1985SE |
| K852141 | Sterile Surgical BladesGES · Traditional | Miltex Instrument Co. | 06/13/1985SE |
| K851157 | Surgimed - Surgical BladesGES · Traditional | Surgimed Corp. | 04/25/1985SE |
| K844759 | Surgical Scalpel Blades & DisposablesGES · Traditional | Cross Country Paper Products Corp. | 01/18/1985SE |
| K844001 | Lance Blades & ScalpelsGES · Traditional | Perry, Div. | 11/08/1984SE |
| K841883 | Surgeon's Blades Sterile BladeGES · Traditional | An-Med Intl. | 06/05/1984SE |
| K841320 | Percutaneous Trig. Finger Release KnifeGES · Traditional | Anapach Effort, Inc. | 04/24/1984SE |
| K834514 | Fascia CutterGES · Traditional | Stryker Corp. | 03/12/1984SE |
| K834195 | Jakobi Surg. Instruments #11 11/13/14GES · Traditional | Imm Enterprises , Ltd. | 01/27/1984SE |
| K834194 | Jakobi Surg. Instruments #1 19/10/26GES · Traditional | Imm Enterprises , Ltd. | 01/27/1984SE |
| K834182 | H.R. Jakobi Surg. Instruments #11 27/37GES · Traditional | Imm Enterprises , Ltd. | 01/27/1984SE |
| K821737 | Disp. Microsurgical KnivesGES · Traditional | Coburn Optical Ind., Inc. | 07/02/1982SE |
| K812516 | Surgical Blades & Scapels (Smpl. W/510K)GES · Traditional | Needle Industries(Usa), Inc. | 10/02/1981SE |
| K812526 | Micro Blade IIGES · Traditional | Vxtra Corp. | 09/16/1981SE |
| K812160 | Microsurgical BladeGES · Traditional | Vxtra Corp. | 08/31/1981SE |
| K812071 | RK IV Surgical BladesGES · Traditional | Santa Barbara Medco, Inc. | 08/31/1981SE |
| K810572 | Blade, Handle, Scalpel Forceps, SurgeryGES · Traditional | Technical Resources, Inc. | 03/20/1981SE |
| K781716 | Blade, 20 Angle/Micro Blade HolderGES · Traditional | Edward Weck, Inc. | 10/24/1978SE |
| K771045 | Blades, ScalpelGES · Traditional | American Safety Razor Co. | 06/22/1977SE |
| K770800 | Handles, Blade, SurgicalGES · Traditional | Lukens Corp. | 05/06/1977SE |
| K770798 | Blades, Surgical, SterileGES · Traditional | Lukens Corp. | 05/06/1977SE |
| K770217 | Lance Ltd. Steri. Stitch Cutter BladeGES · Traditional | Aeroceuticals | 03/30/1977SE |
| K761322 | Surgical BladesGES · Traditional | Richard-Allan Medical Ind., Inc. | 01/06/1977SE |
| K760605 | Lightcast II Carbide BladeGES · Traditional | Merck, Sharp & Dohme | 10/05/1976SE |
| K760364 | Handle, Scalpel, Stainless SteelGES · Traditional | Aeroceuticals | 09/13/1976SE |
| K760363 | Scalpel, Surgical, Sterile StainlessGES · Traditional | Aeroceuticals | 09/13/1976SE |
| K760361 | Blade, Surgical Scalpel, SterileGES · Traditional | Aeroceuticals | 09/13/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0279-2023 Class II | Southmedic SAFETY CARTRIDGE WITH SOUTHMEDIC PLUS SURGICAL BLADE, REF 73-8020, STERILE EOUpon review of its batch record, Southmedic identified that lot # W92761 was not sent out for sterilization… | Southmedic, Inc. | 10/27/2022Open, Classified |
| Z-2755-2016 Class II | Intermediate carton label reads in part as: "Bard-Parker***Stainless Steel Surgical…After receiving a complaint the firm disclosed that Conventional Stainless Steel Surgical Blade catalog… | Aspen Surgical Puerto Rico Corp. | 06/27/2016Terminated |
| Z-0204-2013 Class II | "***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation…Potential for bent tips. | Surgical Specialties Puerto Rico Inc. dba… | 08/15/2012Terminated |
| Z-0203-2013 Class II | "***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation…Potential for bent tips. | Surgical Specialties Puerto Rico Inc. dba… | 08/15/2012Terminated |
| Z-0202-2013 Class II | "***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation…Potential for bent tips. | Surgical Specialties Puerto Rico Inc. dba… | 08/15/2012Terminated |
| Z-0201-2013 Class II | "***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation…Potential for bent tips. | Surgical Specialties Puerto Rico Inc. dba… | 08/15/2012Terminated |
| Z-0522-2010 | Merit Medical Systems, Inc. Futura Safety Scalpels, Futura Safety Scalpel REF/CAT No…Potential sterility breach caused by excessive shipment damage. | Merit Medical Systems, Inc. | 09/29/2009Terminated |
| Z-0862-2009 | Stainless Steel Surgical Blades Part no 4-312B. The product is supplied sterile…Blade may break: Over milling of the blade resulted in tip more narrow than specified. | Miltex, Inc. | 11/17/2008Terminated |
| Z-0013-2008 | Shelf Pack: Bard-Parker Rib-Back Stainless Steel no.11, surgical blade. Unit Package:…Complaints received of rust on the blades of BD Bard-Parker Surgical blades. | Becton Dickinson & Company | 08/10/2007Terminated |
| Z-0012-2008 | Shelf Pack: Bard-Parker Rib-Back Carbon Steel no.11, surgical blade. Unit Package:…Complaints received of rust on the blades of BD Bard-Parker Surgical blades. | Becton Dickinson & Company | 08/10/2007Terminated |
| Z-0767-2007 | Miltex Stainless Steel Disposable Scalpel #22, Part Number 4-422. Each box contains 10…Sterility may be compromised based on incomplete package seals (manufacturer notified Miltex) | Miltex, Inc. | 04/09/2007Terminated |